NCT07169747 Safety, Therapeutic Potential, and Mechanisms of Two Psilocybin Doses, Administered With Psychological Support in Young Adults With Anorexia Nervosa
| NCT ID | NCT07169747 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Region Skane |
| Condition | Anorexia Nervosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2026-04-20 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people with anorexia nervosa to develop healthier ways of thinking. The main questions this study aims to answer are: * Is psilocybin with psychological support safe and well-tolerated? * Does psilocybin with psychological support help lower symptoms of anorexia nervosa? * How might psilocybin work in the brain to support recovery from anorexia? This study will compare psilocybin with psychological support to Treatment as Usual (TAU). Participants in the study will be randomly placed into one of the two groups. There will be 40 patients with anorexia nervosa included, 20 per group. TAU includes the standard care people receive for anorexia nervosa in a specialized eating disorder clinic in Region Skåne, Sweden. Participants will: * Be between 16 and 35 years old and have anorexia nervosa * Take psilocybin (25 mg) by mouth two times, four weeks apart * Receive psychological support before, during, and after each dosing session (including preparation and integration sessions) * Complete questionnaires, have brain scans (magnetic resonance imaging) and blood tests to learn more about how psilocybin may work * Share their personal experiences as part of a qualitative interview This study hopes to learn if psilocybin, when given with the right support, can be a helpful and safe option for people living with anorexia nervosa.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of AN per DSM-5 * Have experienced at least one period of remission (minimum BMI 17) followed by a relapse * Age 16-35 * BMI \>16 * Stable contact with a psychiatric unit * Ability to provide informed consent Exclusion Criteria: * Psychosis, bipolar disorder, substance use disorder, family history of psychosis or bipolar disorder, refusal of birth control, lifetime psychedelic use, unable to washout ongoing medications\* that would interfere negatively with the study drug * Cardiovascular conditions * Resting systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg at screening or baseline * Clinically significant arrhythmias, tachycardia and QT prolongation * History of stroke, myocardial infarction, or other significant cardiovascular events * Seizure disorders or history of epilepsy * Diabetes mellitus, positive drug tests, suicidal intent, allergy or intolerance to drug content, blood or needle phobia * Only for the MRI-part of the study: Metal pieces in the body (contraindicated by fMRI, assessed in each case by MR-technician). Non-compliance to fMRI will not lead to study exclusion * Any other clinically significant medical condition that, in the investigator's opinion, may pose a risk to the participant or interfere with study results * Care under the Swedish Compulsory Psychiatric Care Act (LPT) * 5-HT2A-antagonist need two weeks washout
Contact & Investigator
Pouya Movahed Rad, Associate Professor
PRINCIPAL INVESTIGATOR
Department of Clinical Sciences, Lund University, Sweden
Frequently Asked Questions
Who can join the NCT07169747 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 35 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07169747 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07169747 currently recruiting?
Yes, NCT07169747 is actively recruiting participants. Contact the research team at david.sjostrom@med.lu.se for enrollment information.
Where is the NCT07169747 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT07169747 clinical trial?
NCT07169747 is sponsored by Region Skane. The principal investigator is Pouya Movahed Rad, Associate Professor at Department of Clinical Sciences, Lund University, Sweden. The trial plans to enroll 40 participants.